Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Interventions: Procedure: Transurethral resection of the prostate; Procedure: Holmium Laser Enucleation of the Prostate

• Registration Number: NCT00877669
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-04-06
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 313

Inclusion Criteria

• 50 yrs or greater
• International prostatic symptom score >= 12
• Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
• Able to give fully informed consent

Exclusion Criteria

• Patients with urologic malignancies such as prostate cancer and bladder cancer
• Patients underwent urethral, prostate surgery
• Patients with urethral stricture or bladder diverticulum or bladder neck contracture
• Patients with histories of bacterial prostatitis within 1 year
• seems not to be appropriate to this study by the decision of investigators because of any other reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transurethral resection of the prostate	Transurethral resection of the prostate	TURP group
Holmium Laser Enucleation of Prostate	Holmium Laser Enucleation of the Prostate	HoLEP group

Primary Outcome Measures

Name	Time	Method
The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation	6 months

Secondary Outcome Measures

Name	Time	Method
Ejaculation parameter	6 months after operation
The changes of the hemoglobin and the serum sodium	0 and 1 day after operation
Postoperative hospital stay days and postoperative catheterization days	immediate postoperative period
Complications	During all study periods
The changes of IPSS and QoL parameters	1 month and 3months after operation
Operative time and Resected tissue weight	0 day after operation
The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters	3 and 6 months after operation
The changes of Quality of Life (QoL) parameters	6 months
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters	2 weeks and 3 and 6 months after operation
The changes of voiding frequencies and urgency parameters in Frequency volume chart	3 and 6 months after operation
The changes of ICS male questionnaire (short form) parameters	3 and 6 months after operation
The changes of international index of erectile function (IIEF)-15 parameters	6 months after operation

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of